Engineering Technician

Position Summary:

The Engineering Technician is responsible for providing technical support to the Engineering and Manufacturing teams within an electromechanical medical device assembly environment. This role is responsible for supporting manufacturing product builds, process improvements, equipment validation, troubleshooting, document control activities, and production readiness efforts.

This position works closely with Manufacturing and Quality Engineering teams to diagnose manufacturing issues, restore production capability, and prevent recurrence through process improvements. The technician supports new and existing manufacturing lines, assists with product and equipment launches, evaluates production data, and documents findings to support manufacturing changes. Success in this role requires strong analytical and hands-on troubleshooting skills, the ability to work independently in a dynamic factory environment, and a focus on continuous improvement and operational excellence. This position will follow compliance with applicable regulatory and quality system requirements, including ISO 13485, MDSAP, FDA Quality System Regulations, and company procedures.

Location: 1049 W Ridge Road, Greece, NY 14615

Position Responsibilities:

• Follow engineering direction to perform hands-on evaluation, repair, rework, and modification of electromechanical assemblies and components in accordance with approved procedures and quality standards.
• Execute engineering test plans created by the manufacturing engineering team, and collect data to support product verification, process validation, root cause investigations, and process improvements.
• Work closely with production lines to gain a thorough understanding of manufacturing processes, materials, and equipment, enabling effective troubleshooting and continuous improvement of production issues.
• Assist the manufacturing engineering team with product and process development activities, including engineering builds, new product introductions, and manufacturing transfers.
• Write and maintain standard operating procedures (SOPs) and assist with training Production Operators and Technicians on SOPs.
• Support process validation activities (IQ/OQ/PQ), data collection, and continuous improvement initiatives to enhance quality, efficiency, and manufacturability.
• Perform testing, troubleshooting, and root cause investigations of products, equipment, and manufacturing processes to resolve technical issues.
• Create, maintain, and revise controlled manufacturing documentation, including work instructions, test methods, engineering change records, and assembly procedures.
• Ensure compliance with ISO 13485, MDSAP, FDA regulations, and internal quality system requirements while supporting audits, CAPA activities, change control, and risk management processes.
• Less than 10% travel. 
• Other duties as needed.

Required Skills & Education:

• Either a High school diploma or equivalent AND 4+ years of experience working as a production or engineering technician in a manufacturing environment,

     OR Associate's degree or greater in a STEM discipline AND 1+ years of experience working as a production or engineering technician in a manufacturing environment.

• Proficient in Microsoft Office applications, including Excel 1 (data entry, formulas, charts, and basic data analysis), Word (document creation and revision), Outlook, and Teams.
• An understanding of complex hardward equipment and the ability to troubleshoot electromechanical assemblie (identify root causes using structured problem-solving methods).
• Demonstrated understanding of Good Documentation Practices (GDP) and document control requirements.

Desired Skills:

• Bachelor’s Degree (BS) in Electrical, Mechanical, or Manufacturing Engineering or Engineering Technology.
• Strong Written and Verbal communication skills.
• Experience with writing and maintaining work instructions.
• Experience supporting manufacturing engineering in a medical device, healthcare technology, electronics, aerospace, or other regulated manufacturing environment.
• Working knowledge of SAP or other enterprise resource planning (ERP) systems.
• Experience with process improvement methodologies such as Lean Manufacturing, Kaizen, or Six Sigma.
• Experience supporting engineering investigations, validation activities, or new product introduction efforts.

Work Environment:

Manufacturing Production & Labs

Physical Requirements:

• Standing: 50-75%                                               
• Walking: 25-50%
• Sitting: 1-25%
• Bending/kneeling: 25-50%
• Carrying, Pushing or Pulling: 25-50%
• Lifting 20-35 pounds: 1-25%
• Lifting 35-50 pounds: 1-25%
• Lifting 50-100 pounds: 0%